Identity
- Trade Name
- VENTANA PD-L1(SP142) CDX ASSAY FDA PMA
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1 FDA PMA
Identifiers
- PMA Number
- P160002 FDA PMA
- FDA Product Code
- PLS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay classified as an Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1. It utilizes a rabbit monoclonal anti-PD-L1 clone SP142 to detect PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue. The assay quantifies PD-L1 status by assessing the proportion of tumor area occupied by PD-L1–expressing tumor-infiltrating immune cells (% IC) of any intensity. Results are generated using the OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument.
This assay is intended for laboratory use on the VENTANA BenchMark ULTRA platform and requires FFPE tissue samples. It is supplied as a single-use diagnostic device, with no regulatory indication of sterility or MRI compatibility. The assay is authorized under an FDA Premarket Approval (PMA) and is categorized as a Class III device. Storage and handling must comply with standard immunohistochemistry assay protocols, including proper fixation and processing of tissue samples.
Frequently asked questions
What type of tissue samples is the VENTANA PD-L1 (SP142) Assay designed to analyze, and how is it processed before testing?
The VENTANA PD-L1 (SP142) Assay is specifically designed to analyze formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue samples. Before testing, the tissue must undergo standard fixation and processing procedures to prepare it for immunohistochemical staining on the VENTANA BenchMark ULTRA platform.
Is the VENTANA PD-L1 (SP142) Assay intended for single-use or repeated use, and what does this mean for clinical workflows?
The VENTANA PD-L1 (SP142) Assay is supplied as a single-use diagnostic device, meaning each assay kit is intended for one use only. This ensures consistency and reliability in results, as reuse could compromise sterility or performance. Clinicians must order a new kit for each test, which may require planning to avoid delays in workflow.
How is the PD-L1 status determined using this assay, and what clinical significance does the result have?
The assay quantifies PD-L1 status by measuring the percentage of tumor area occupied by PD-L1–expressing tumor-infiltrating immune cells (% IC) of any intensity. If PD-L1 expression is detected in **≥5% of immune cells**, it is associated with an increased objective response rate (ORR) in patients treated with TECENTRIQ (atezolizumab), as demonstrated in a non-randomized study. This helps guide potential immunotherapy decisions.
What equipment and reagents are required to perform the VENTANA PD-L1 (SP142) Assay, and where does the testing take place?
The assay requires the **VENTANA BenchMark ULTRA** automated staining instrument, along with the **OptiView DAB IHC Detection Kit** and **OptiView Amplification Kit**. Testing is performed exclusively in a laboratory setting, as it involves specialized immunohistochemical staining of FFPE tissue samples. The assay is not compatible with other platforms or manual staining methods.
How should the assay kits be stored, and are there any special handling requirements beyond standard IHC protocols?
While specific storage conditions are not detailed in the data, the assay must adhere to **standard immunohistochemistry assay protocols**, including proper handling of FFPE tissue samples and reagents. Kits should be stored according to manufacturer guidelines (typically refrigerated or at room temperature, as indicated on packaging) to maintain integrity until use. Avoid exposure to extreme temperatures or contamination.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home | Ventana
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160002 | Class III | Active |
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Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P160002 24 fields · synced Oct 6, 2026